An Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis
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ClinicalTrials.gov Identifier: NCT00941278 |
Recruitment Status :
Completed
First Posted : July 17, 2009
Last Update Posted : July 7, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriasis | Drug: PH-10 (0.001% Rose Bengal) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | April 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: PH-10 Treatment |
Drug: PH-10 (0.001% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis. |
- The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale. [ Time Frame: 28 days ]
- The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality). [ Time Frame: 8 weeks ]
- Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
- Plaque Response score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
- Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men or women, age 18 or older.
- Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas).
- Fitzpatrick skin type I-VI.
- Written informed consent by the subject or legal guardian.
Exclusion Criteria:
- Women of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
- Subjects who have received PUVA or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
- Subjects who have received UVB light therapy within 14 days of study initiation.
- Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of study initiation.
- Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of study initiation.
- Subjects who have received any approved or investigational biologic drug therapy for psoriasis within 90 days or 5 half-lives of study initiation.
- Subjects who have participated in a clinical research study within 28 days of study initiation.
- Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
- Subjects with clinical conditions that, in the opinion of the Investigator may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941278
United States, Florida | |
International Dermatology Research | |
Miami, Florida, United States, 33144 | |
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 |
Study Director: | Eric Wachter, PhD | Provectus Pharmaceuticals |
Responsible Party: | Eric Wachter/Vice President, Provectus Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00941278 |
Other Study ID Numbers: |
PH-10-PS-22 |
First Posted: | July 17, 2009 Key Record Dates |
Last Update Posted: | July 7, 2010 |
Last Verified: | July 2010 |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |